Pessary device with longitudinal flexibility

ABSTRACT

A non-expandable pessary device, the pessary device having a top, a base, a sidewall that extends between the top and the base, a length measured from the top to the base, a longitudinal axis, a maximum diameter, and a minimum diameter that is less than the maximum diameter, the sidewall, top and base forming an enclosed outer periphery defining a total area of the device. The pessary device has radial symmetry about the longitudinal axis and has a pressure region adapted to extend between an anterior vaginal wall and a posterior vaginal wall of a user to provide pressure on the user&#39;s urethra through the anterior vaginal wall.

FIELD OF INVENTION

This application relates to pessary devices for relief of femaleincontinence. More particularly, the present invention relates topessary devices with longitudinal flexibility.

BACKGROUND OF THE INVENTION

Urinary incontinence, in which the ordinary bodily muscle functions failto prevent unintended leakage of urine, is a common malady among women,particularly older women. It is estimated that up to 50% of womenoccasionally leak urine involuntarily, and that approximately 25% ofwomen will seek medical advice at some point in order to deal with theproblem. Stress incontinence, the most common type of urinaryincontinence, refers to the involuntary loss of urine resulting fromabdominal pressure rise, occurring during exercise, coughing, sneezing,laughing, etc. When stress incontinence occurs, it is usually the resultof the abnormal descent of the urethra and bladder neck below the levelof the pelvic floor. Many women wear sanitary napkins or diapers inorder to deal with incontinence, and some women resort to surgicalprocedures.

Pessary devices are known to help relieve involuntary urination in afemale. Such devices are designed for arrangement in the vagina forcompressive action on and support of the bladder. Typical pessarydevices are large in width during use, and may elastically expand,inflate, or unfold to provide compressive action within the vagina. Suchpessary devices can be uncomfortable for a user and/or can require theuser to activate or operate the device prior to or upon insertion of thepessary device into the vagina. This can result in an undesirable usageexperience.

As such, there remains a need for a pessary device with improved comfortduring use. There also remains a need for a pessary device that is smallin size yet effective. In addition, there remains a need for adisposable pessary device that can be used daily.

SUMMARY OF THE INVENTION

A non-expandable pessary device is provided. The pessary device has atop, a base, a sidewall that extends between the top and the base, alength measured from the top to the base, a longitudinal axis, a maximumdiameter, and a minimum diameter that is less than the maximum diameter.The sidewall, top, and base form an enclosed outer periphery defining atotal area of the device. The pessary device has radial symmetry aboutthe longitudinal axis. A pressure region is adapted to extend between ananterior vaginal wall and a posterior vaginal wall of a user to providepressure on the user's urethra through the anterior vaginal wall. Thepressure region has the maximum diameter. The pessary device further hasa flexile region having the minimum diameter. The flexile region is moreflexible than the pressure region. The maximum diameter is less than 25mm and the maximum length is less than 60 mm.

Also provided is an intravaginal pessary device. The pessary device hasa top, a base, a sidewall that extends between the top and the base, alength measured from the top to the base, a longitudinal axis, a maximumdiameter, a second diameter, and a minimum diameter that is less thanthe maximum diameter and the second diameter. The sidewall, top and baseform an enclosed outer periphery defining a total area of the device.The pessary device has radial symmetry about the longitudinal axis andhas a first pressure region adapted to extend between an anteriorvaginal wall and a posterior vaginal wall of a user to provide pressureon the user's urethra through the anterior vaginal wall. The firstpressure region comprising the maximum diameter. The maximum diameter isless than 25 mm and the length is less than 60 mm, the pessary devicehas a second pressure region comprising the second diameter. The secondpressure region being provided apart from the first pressure region. Thepessary device also has a flexile region comprising the minimum diameterthat is disposed between the first pressure region and the secondpressure region.

Further provided is an intravaginal pessary device. The pessary deviceis non-expandable, has a top, a base, a sidewall that extends betweenthe top and the base, a length measured from the top to the base, alongitudinal axis, a maximum diameter, and a minimum diameter that isless than the maximum diameter. The sidewall, top and base form anenclosed outer periphery defining a total area of the device. Thepessary device has radial symmetry about the longitudinal axis and has apressure region adapted to extend between an anterior vaginal wall and aposterior vaginal wall of a user to provide pressure on the user'surethra through the anterior vaginal wall. The pressure region has themaximum diameter and the pessary device further having a flexile regioncomprising the minimum diameter. The flexile region is more flexiblethan the pressure region, the maximum diameter is less than 25 mm, andthe maximum length is less than 60 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter of the present invention, itis believed that the invention can be more readily understood from thefollowing description taken in connection with the accompanyingdrawings, in which:

FIG. 1A is a side view of a pessary device.

FIG. 1B is a perspective view of the pessary device of FIG. 1A.

FIG. 2A is a side view of a pessary device.

FIG. 2B is a perspective view of the pessary device of FIG. 2B.

FIG. 3 is a cross-section view of a pessary device.

FIG. 4 is a cross-section view of a pessary device.

FIG. 5 is a cross-section view of a pessary device.

FIG. 6 is a perspective view of a pessary device.

FIG. 7 is a side view of a pessary device.

FIG. 8 is a side view of a pessary applicator, housing the pessary ofFIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to pessary devices that are insertedinto the female vagina to help control involuntary urinary incontinence.The pessary devices are non-expandable, small in size, and can provideimproved comfort during use. The pessary devices can include a firstportion having a first width that is adapted to extend between ananterior vaginal wall and a posterior vaginal wall of a user to providepressure on the user's urethra through the vaginal wall. The firstportion can include the maximum width of the pessary. The pessary devicecan also include a second portion having a second width provided distalfrom the first portion. The second portion can include the minimum widthof the pessary device. The second portion can be more flexible than thefirst portion, and the first portion can be more resistant than thesecond portion under high stress conditions, such as, for example, whenthe user coughs. This can provide for a small and comfortable, yeteffective, pessary device.

A woman with stress incontinence can experience involuntary loss ofurine with increases in abdominal pressure, such as, for example, duringexercise, coughing, sneezing, laughing, or valsalva maneuvers. This lossof urine is thought to occur because the muscles and connective tissuethat support the bladder and/or urethra are weakened or injured andcannot fully support the bladder and/or urethra during stress incidents,leading to leaks. Physical changes due to childbirth, menopause, injury,surgery, and pelvic organ prolapse can often cause stress incontinence.Surprisingly, the pessary devices described herein can provideresistance sufficient to prevent leakage during increases in abdominalpressure while remaining flexible and small enough to provide comfortduring wear.

As used herein, “applicator” refers to a device or implement thatfacilitates the insertion of the pessary device into an external orificeof a mammal. Exemplary applicators include telescoping, tube andplunger, and compact applicators.

The term “joined” or “attached” as used herein, encompassesconfigurations in which a first element is directly secured to a secondelement by affixing the first element directly to the second element,configurations in which the first element is indirectly secured to thesecond element by affixing the first element to intermediate member(s)which in turn are affixed to the second element, and configurations inwhich first element is integral with second element, i.e., first elementis essentially part of the second element.

As used herein, the term “non-expandable” refers to devices that do notexpand prior to or during use, such as, for example, devices that do notsubstantially increase in size or volume prior to or during use. Forexample, non-expandable devices have a diameter and/or volume that doesnot substantially increase. In contrast, “expandable” as used herein,refers to devices that do increase in size or volume prior to or duringuse, such as, for example, devices that increase in diameter and/orlength, absorb fluid into a fibrous or absorbent gelling materialstructure, or otherwise change from a first size or volume to a secondsize or volume, such as, for example, by inflation, absorption,mechanically, user action, or by other means. Insubstantial changes to anon-expandable device as a result of any thermal expansion that couldoccur at body temperatures are not considered “expansion.”

A “pessary device” or more particularly an “incontinence pessary device”as used herein refers to devices specifically designed, configured,and/or adapted for placement into a vagina in order to reduce theoccurrence and/or severity of female urinary incontinence. A “pessarydevice” can include any type of substantially non-absorbent structurefor the purpose of reducing urine leakage and/or supporting a prolapseduterus and/or bladder. A pessary device does not include a menstrualtampon.

As used herein, the term “vaginal canal” refers to the internalgenitalia of the human female in the pudendal region of the body. Theterms “vaginal canal” or “within the vagina” as used herein are intendedto refer to the space located between the introitus of the vagina(sometimes referred to as the sphincter of the vagina) and the cervix.

An exemplary pessary device 10 is shown in FIGS. 1A and 1B. The pessarydevice 10 includes an upper portion 20, a lower portion 30, a middleportion 40, a pressure region 50 of the upper portion 20, a pressureregion 60 of the lower portion 30, a maximum width W₁, a minimum widthW₂, a slope 80 extending from the upper portion 20 to the middle portion40, a slope 90 from the middle portion 40 to the lower portion 30, alongitudinal axis (L) and a transverse axis (T). As shown in FIGS. 1Aand 1B, the pessary device 10 can have a top 100 that includes a convexportion 110, a base 120 that includes a convex portion 130, and sides140 that include concave portions 150. The pessary device can besymmetric about the longitudinal axis, including for example, whereinthe base is circular and symmetric about the longitudinal axis. Thepessary device can include a third width W₃ that is greater than minimumwidth W₂, and convex portion 110 can be aligned with maximum width W₁ toprovide pressure region 50, and convex portion 130 can be aligned withmaximum width W₁ to provide pressure region 60. In addition, concaveportion 150 can be aligned with minimum width W₂ to form flexile region160.

FIGS. 2A and 2B show a pessary device 10. The pessary device 10 includesan upper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum width W₁, a minimum width W₂, a slope 80 extendingfrom the upper portion 20 to the middle portion 40, a slope 90 from themiddle portion 40 to the lower portion 30, a longitudinal axis (L) and atransverse axis (T). As shown in FIGS. 2A and 2B, the pessary device 10can have a top 100 that includes a convex portion 110, a base 120 thatincludes a convex portion 130, and sides 140 that include concaveportions 150. The pessary device 10 can also include a flexile region160. The pessary device shown in FIGS. 2A and 2B has an upper slope 80that is greater than the upper slope 80 of the pessary device shown inFIGS. 1A and 1B. In addition, the pessary device shown in FIGS. 2A and2B has a lower slope 90 that is greater than the lower slope 90 of thepessary device shown in FIGS. 2A and 2B.

FIG. 3 shows a pessary device 10 taken along line 3-3 of FIG. 1. Thepessary device 10 includes an upper portion 20, a lower portion 30, amiddle portion 40, a pressure region 50 of the upper portion 20, apressure region 60 of the lower portion 30, a maximum width W₁, aminimum width W₂, a slope 80 extending from the upper portion 20 to themiddle portion 40, a slope 90 from the middle portion 40 to the lowerportion 30, a longitudinal axis (L) and a transverse axis (T). As shownin FIG. 3, the pessary device 10 can have a top 100 that includes aconvex portion 110, a base 120 that includes a convex portion 130, andsides 140 that include concave portions 150. As shown in FIG. 3, thepessary device 10 can have outer wall 250 and an interior 200 defined byinner walls 240 that is hollow in region 220. The hollow region 220 canbe provided at one or both ends. In addition, the pessary device 10 canhave a portion of the interior 200 that is solid.

FIG. 4 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum width W₁, a minimum width W₂, a slope 80 extendingfrom the upper portion 20 to the middle portion 40, a slope 90 from themiddle portion 40 to the lower portion 30, and a longitudinal axis (L).As shown in FIG. 4, the pessary device 10 can have a top 100 thatincludes a convex portion 110, a base 120 that includes a convex portion130, and sides 140 that include concave portions 150. As shown in FIG.4, the pessary device 10 can have an interior 200 that is hollow. Thepessary device has inner walls 240 that define interior 200 and hollowregion 220. In addition, the inner walls 240 can have the same or asimilar profile as the outer walls 250.

FIG. 5 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a maximum width W₁, a minimum width W₂, a slope 80 extendingfrom the upper portion 20 to the middle portion 40, a slope 90 from themiddle portion 40 to the lower portion 30, and a longitudinal axis (L).As shown in FIG. 5, the pessary device 10 can have a top 100 thatincludes a convex portion 110, a base 120 that includes a convex portion130, and sides 140 that include concave portions 150. As shown in FIG.5, the pessary device 10 has an interior 200 that is hollow. The pessarydevice has inner walls 240 that define interior 200 and hollow region220. The hollow region 220 can have a first profile defined by innerwalls 240 and a different profile defined by outer walls 250, such as,for example, where the hollow region 220 is in the form of a tube.

FIG. 6 shows a pessary device 10. The pessary device 10 includes anupper portion 20, a lower portion 30, a middle portion 40, a pressureregion 50 of the upper portion 20, a pressure region 60 of the lowerportion 30, a slope 80 extending from the upper portion 20 to the middleportion 40, a slope 90 from the middle portion 40 to the lower portion30, and a longitudinal axis (L). As shown in FIG. 6, the pessary device10 can have a top 100 that includes a convex portion 110, a base 120that includes a convex portion 130, and sides 140 that include concaveportions 150. As shown in FIG. 6, the pessary device 10 can have aninterior 200 that is hollow. In addition, as shown in FIG. 6, thepessary device 10 can have an opening on one or more of top 100 and/oron base 120.

The pessary device 10 can include an overwrap 300 and/or a withdrawalmember 310, such as, for example, as shown in FIG. 7. In addition, FIG.7 shows that withdrawal member 310 can be attached to overwrap 300.

The pessary device can be inserted in any suitable manner, such as, forexample, using an applicator. FIG. 8 shows an applicator 410 thatincludes an insertion member 420 and a plunger 440. The insertion member420 has an insertion end 421 and a withdrawal end 422 opposite theinsertion end 421. The insertion member 420 also can include a barrelregion 450 adapted to contain the pessary device, and a grip region 430that can be an indentation region 424 provided opposite the insertionend 421, such as, e.g., proximal to the withdrawal end 422. The gripregion 430 can include one or more grip elements 423.

Generally, the pessary device does not change in size during the usageexperience, that is, the pessary device is the same size and diameterprior to insertion by the user as well as during use and removal. Forexample, the pessary device is not expandable or inflatable from itsoriginal size and the pessary device is not compressed for insertioninto the user's body, nor is the pessary device compressed forwithdrawal from the user's body. A portion or region of the pessarydevice can flex or be deformed, such as, for example, in the regionhaving the minimum diameter, but the pessary device does not expand andreturns to the original configuration after deformation. As such, thepessary device does not include any mechanical or other means thatrequires the user to change the size or shape of the pessary deviceduring use, such as, for example, before or after insertion or prior towithdrawal. This provides for a pessary device that has a size uponwithdrawal that is the same as the size during use, which can providefor improved comfort during use and withdrawal.

The pessary device can have a first width and a second width, whereinthe first width is greater than the second width. The first width cancorrespond to the top, the bottom, or both, and the second width cancorrespond to the mid-section. In addition, the region having the firstwidth can have a first resistance to pressure and the region having thesecond width can have a second resistance to pressure, the firstresistance being greater than the second resistance. For example, theregion having the first resistance can have a first flexibility that isgreater than a flexibility of the region having the second resistance.

The region having the first width can be convex and can extend betweenthe anterior vaginal wall and the posterior vaginal wall of a consumerto provide pressure on the urethra through the vaginal wall. Inaddition, the pessary device can have a second convex portion having anincreased width compared to the second width that can provide pressureon the urethra through the vaginal wall at a point distal from the firstconvex portion. The first convex portion and the second convex portioncan be separated by any suitable distance, such as, for example, by atleast about 5 mm, at least about 10 mm, at least about 15 mm, at leastabout 20 mm, at least about 25 mm, at least about 30 mm, at least about35 mm, at least about 40 mm, at least about 45 mm, at least about 50 mm,or any other suitable distance.

The pessary device can have any suitable number of convex portions,including for example, four or fewer convex portions, three or fewerconvex portions, two or fewer convex portions, one convex portion, orany other suitable number of convex portions.

The region having the first width can be any suitable shape, such as,for example, a convex shape that provides pressure to the vaginal wall,such as, for example, a lobe or other protuberance. The region havingthe first width can have a substantially circular cross-section. Thepessary device can also include a region having the second width thatcan provide flexibility to the pessary device, such as, for example, byallowing bending or movement at the region. The region having the secondwidth can be any suitable shape, such as, for example, concave,indented, or the like, and can have suitable cross-section, such as, forexample, a substantially circular cross-section.

The region having the first width can have a first flexibility and theregion having the second width can have a second flexibility, the firstflexibility being greater than the second flexibility. Flexibility canbe measured in any suitable manner, such as, for example, by the GardnerImpact Test using a Gardner Variable Impact Tester in accordance withASTM-D 5420-04.

The pessary device can provide resistance to force when placed inside awoman's vagina. For example, when the pessary device is inserted intothe vagina, increases in abdominal pressure can act as a force on thepessary device through the vaginal wall. When the pessary device isdisposed in the vagina lengthwise, that is, with the top of the pessarydevice positioned toward the cervix, the bottom of the pessary devicepositioned toward the introitus, and the length of the pessary devicegenerally aligned with the length of the vagina, increases in abdominalpressure can act on the side of the pessary device, perpendicular to thelength of the pessary device. Of course, increases in abdominal pressurecan act on other regions of the pessary device, in addition oralternatively to acting on the side of the pessary device, including forexample, when the pessary device is inserted into the vagina in anorientation other than lengthwise.

Despite its small size, the pessary device can provide a resistance toforce of greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi under about 2 newtons offorce. For example, in certain embodiments, the pessary device canprovide a resistance to force of greater than about 20 psi under about 2newtons of force and greater than about 25 psi under about 3 newtons offorce. The pessary device also can resist compression under pressure.For example, the pessary device can compress less than about 20% underabout 2 newtons of force, less than about 15% under about 2 newtons offorce, less than about 14% under about 2 newtons of force, less thanabout 13% under about 2 newtons of force, less than about 12% underabout 2 newtons of force, less than about 11% under about 2 newtons offorce, less than about 10% under about 2 newtons of force, less thanabout 9% under about 2 newtons of force, less than about 8% under about2 newtons of force, less than about 7% under about 2 newtons of force,less than about 6% under about 2 newtons of force, less than about 5%under about 2 newtons of force, less than about 4% under about 2 newtonsof force, less than about 3% under about 2 newtons of force, less thanabout 2% under about 2 newtons of force, or less than about 1% underabout 2 newtons of force. For example, the pessary device can compressless than about 20% under about 2 newtons of force, less than about 15%under about 2 newtons of force, less than about 14% under about 2newtons of force, less than about 13% under about 2 newtons of force,less than about 12% under about 2 newtons of force, less than about 11%under about 2 newtons of force, less than about 10% under about 2newtons of force, less than about 9% under about 2 newtons of force,less than about 8% under about 2 newtons of force, less than about 7%under about 2 newtons of force, less than about 6% under about 2 newtonsof force, less than about 5% under about 2 newtons of force, less thanabout 4% under about 2 newtons of force, less than about 3% under about2 newtons of force, less than about 2% under about 2 newtons of force,or less than about 1% under about 2 newtons of force.

The pessary devices can provide a varied resistance to force along thelongitudinal axis of the pessary device. For example, the pessary devicecan provide a resistance to force that is greater at the maximumdiameter regions and smaller at the minimum diameter regions. Inaddition, the pessary device can compress differently along thelongitudinal axis at different regions. For example, when force isapplied to the side of the pessary, the minimum diameter region cancompress at least about 5% more than the maximum diameter region underthe same amount of pressure (for example, under about 200 g/m2 offorce), at least about 10% more than the maximum diameter region underthe same amount of pressure, at least about 15% more than the maximumdiameter region under the same amount of pressure, at least about 20%more than the maximum diameter region under the same amount of pressure,or at least 25% more than the maximum diameter region under the sameamount of pressure. Any suitable amount of force can be applied, suchas, for example, from about 200 g/m2 of force to about 1500 g/m2 offorce, from about 200 g/m2 of force to about 1400 g/m2 of force, fromabout 300 g/m2 of force to about 1200 g/m2 of force, or from about 400g/m2 of force to about 800 g/m2 of force.

The amount of resistance to force and the amount of compression underforce provided by the pessary device as a whole or provided by thedifferent regions of the pessary device can be measured in any suitablemanner. For example, one suitable method employs a Universal ConstantRate Elongation/Tensile Tester with computer interface (MTS, EdenPrairie, Minn.). The method measures the force required to compress thepessary device resting on its side at 0.8 mm at a rate of 20 mm per min.For this method, the load probe tip is 5 mm in diameter and the tip issemi-spherical in shape. In addition, the resting fixture is acylindrical steel plate 152 mm in diameter and 13 mm thick. The pessarydevice is placed on the steel table and the crosshead moves at 20mm/min. When a force of 2 grams is exhibited on the pessary device, thecrosshead automatically zeroes out and moves an additional 0.8 mm. Theprobe cycles back, and data is acquired at a rate of 100 Hz. This methodmeasures the peak force in grams versus the amount of compression in mm.For pessary devices having varying diameters or widths, such as, forexample, pessary devices having a maximum diameter or width and aminimum diameter or width, resistance to force at the different regionscan be measured using this method. For example, for a pessary device asshown in FIGS. 1A and 1B, resistance to force at the maximum widthregions W₁ and W₃ can be measured using a steel plate that is larger insize than the pessary device as the resting fixture. Resistance to forceat the minimum diameter region W₂ can be measured using a single rodthat contacts the minimum diameter region but not the maximum diameterregions.

Generally, the pressure region can be resistant such that the pressureregion can provide pressure to the vaginal wall. The pressure regionprovides resistance under high stress pressures typical of the humanvagina, such as, for example, by providing a maximum pressure to theurethra through the vaginal wall greater than about 5 psi, such as, forexample, greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi. In addition, thepressure region can provide a maximum urethral closure of greater thanabout 1.0 mm, such as, for example, greater than about 1.1 mm, greaterthan about 1.2 mm, greater than about 1.3 mm, greater than about 1.4 mm,such as, for example, greater than about 1.5 mm, greater than about 1.6mm, greater than about 1.7 mm, greater than about 1.8 mm, or greaterthan about 1.9 mm. In addition, or alternatively, the pressure regioncan compress less than about 1 mm when measured under 0.5 psi when theforce is applied from one side of the pressure region to the oppositeside of the pressure region at the region of maximum width in thedirection perpendicular to the longitudinal axis.

Maximum pressure to the urethra and maximum urethral closure can bemeasured using any suitable method, such as, for example, by using thecomputational model described in U.S. Patent Appln. No. 2007/0027667.For example, a computation model simulating the human internal pelvicenvironment can be used. In certain embodiments, thirteen nodes on theurethra in the simulation that are both on the back wall toward thevagina and in the middle of the body on the sagittal plane can bechosen. The points should be spread even along the length of the urethrawith the first point at the bottom edge of the urethra and the lastpoint at the bladder neck. Node vs. time vs. Von Mises stress should beobtained using a suitable software program, such as, for example,LS-Prepost, for all chosen nodes. The data columns are then matched todetermine the y position vs. time vs. Von Mises stress. Generally, onlythe data that is at the simulation end point should be selected andy-position vs. Von Mises is then plotted.

The flexile region, on the other hand, is more flexible than andprovides less resistance than the pressure region. Addition of theflexile region can allow the pessary device to flex in the longitudinaldirection as well at the lateral direction. For example, the pessarydevice can compress more than about 1 cm when measured under 0.5 psiwhen the force is applied from the top to the base along thelongitudinal axis. In addition, or alternatively, the flexile region canprovide a bending region that facilitates the pessary device bendingfrom side to side.

The pessary device can be a unitary construction. For example, thepessary device can include a continuous outer shell that defines theentire exterior surface of the pessary device. The outer shell can besmooth or textured. The outer shell may be permeable to fluid, such as,for example, by the inclusion of holes, pores, or other suitableopenings. Alternatively, the outer shell can be impermeable to fluidsuch that fluid cannot enter the device. In addition, the pessary devicecan include an opening in the top and/or base. In certain embodiments,the pessary device can include an opening in the top and/or base and theouter shell is not permeable to fluid such that fluid cannot enter thedevice except through the opening in the top and/or base.

Suitable pessary devices can be solid or can have a hollow interior. Forhollow devices, the pessary device can have an outer periphery defininga total area of the device and an inner periphery defining an open areaof the device. The open area can be any suitable size, such as, forexample, between about 5% to about 95% of the total area, such as, forexample, from about 10% to about 90% of the total area, from about 15%to about 85% of the total area, or from about 20% to about 80% of thetotal area. In addition, the pessary device also can have a wallthickness that is suitable to maintain the pessary configuration. Thewall thickness can be greater than about 1 mm, such as for example,about 2 mm, about 3 mm, about 4 mm, about 5 mm, or greater. The wallthickness can be constant or varied along the length of the pessarydevice and/or around the circumference of the pessary device.

The pessary device can have any suitable shape having a varied widthalong the longitudinal axis, such as, for example, a shape having avaried width that is symmetrical with respect to the longitudinal axis,such as, for example, a teardrop, an apple, a pear, an hourglass, awaisted cylinder, a figure-8 shape, a peanut shape, a heart-shape, alight bulb shape, a bottle shape, a vase shape, or any other suitableshape. In addition, the shape can have a varied width and can besymmetrical with respect to both the longitudinal and lateral axis, suchas, for example, an hourglass, a waisted cylinder, a figure-8 shape, apeanut shape, or any other suitable shape. Alternatively, the pessarydevice can have an asymmetrical shape, such as, for example, a B-shapeor a P-shape. The pessary device can be symmetrical at one region andasymmetrical at another region, such as, for example, where the pessarydevice has a symmetrical pressure region and an asymmetrical flexileregion. Generally, the pessary device can have a varying width that canprovide varying pressure along the user's urethra. For example, thepessary device can have a convex portion that can correspond to thepressure region. In addition, the pessary device can have a minimumwidth region that can be a concave region. The concave region cancorrespond to the flexile region.

The pessary device can be hourglass shaped. For example, as shown inFIGS. 1-2, the pessary device can have upper and lower portions joinedtogether by a waistline portion, with the upper and lower portionshaving widths that are both greater than a width of the waistlineportion such that the pessary device has a generally hourglassconfiguration. In this configuration, the upper portion of the pessarydevice can have a top and the lower portion of the pessary device canhave a base, and the pessary device can have sloping upper and lowerwall sections joining the top and the base with the waistline portion.In addition, the waistline portion can include the minimum width of thepessary device. The upper and lower portions can have generally coequalmaximum widths, or the upper and lower portions can have differentmaximum widths, such as, for example, where the upper portion has amaximum width greater than the lower portion or where the lower portionhas a maximum width greater than the upper portion.

Generally, the pessary device includes at least one maximum width and atleast one minimum width, where the minimum width is smaller than themaximum width. The pessary device can include a first portion having amaximum width, a second portion having a maximum width, and a thirdportion that has a minimum width. The maximum width of the first portionand the maximum width of the second portion can be separated by adistance that is greater than about 10% of the length of the pessarydevice, such as, for example, by a distance greater than about 5 mm,greater than about 10 mm, greater than about 15 mm, greater than about20 mm, greater than about 25 mm, greater than about 30 mm, greater thanabout 35 mm, greater than about 40 mm, greater than about 45 mm, ormore. In certain embodiments, the pessary device provides pressure atmid-urethra, the bladder neck, or both. In addition, in certainembodiments, the pessary device provides higher pressure at themid-urethra, the bladder neck, or both and provides lower pressure atthe area between the mid-urethra and the bladder neck. For example, thepressure region can provide pressure at levels about 25% higher than thepressure provided by the flexile region, such as, for example, at levelsabout 30% higher, about 35% higher, about 40% higher, about 45% higher,about 50% higher, about 55% higher, about 60% higher, or more.

The pessary device can have a slope from the maximum width to theminimum width. Any suitable slope can be used, including for example,about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, about 1.5 mm,about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6mm, about 7 mm, about 8 mm, or more, such as, for example, a slope fromabout 0.25 mm to about 5 mm, or a slope from about 0.5 mm to about 4 mm,or any other suitable range.

Suitable pessary devices are typically smaller in size than conventionalpessary devices. For example, the pessary devices have a maximum width,a length, and/or a volume that is smaller or less than that ofconventional pessary devices.

The pessary devices can have any suitable maximum width, such as, forexample, a maximum width of less than 35 mm, such as, for example, lessthan 34 mm, less than 33 mm, less than 32 mm, less than 31 mm, less than30 mm, less than 29 mm, less than 28 mm, less than 27 mm, less than 26mm, less than 25 mm, less than 24 mm, less than 23 mm, less than 22 mm,less than 21 mm, less than 20 mm, less than 19 mm, less than 18 mm, lessthan 17 mm, less than 16 mm, less than 15 mm, less than 14 mm, less than13 mm, less than 12 mm, less than 11 mm, or less than 10 mm, including,for example, a maximum width of from about 10 mm to about 35 mm, fromabout 10 mm to about 25 mm, from about 13 mm to about 25 mm, or fromabout 15 mm to about 22 mm. The maximum width or width is typicallymeasured at the widest portion of the pessary device substantiallyperpendicular to the longitudinal axis.

The pessary devices can have any suitable minimum width that is smallerthan the maximum width, including, for example, a minimum width fromabout 40% to about 95% of the maximum width, from about 40% to about 90%of the maximum width, from about 40% to about 85% of the maximum width,from about 40% to about 80% of the maximum width, from about 45% toabout 75% of the maximum width, or from about 50% to about 70% of themaximum width, such as, for example, about 45% of the maximum width,about 50% of the maximum width, about 55% of the maximum width, about60% of the maximum width, about 65% of the maximum width, or about 70%of the maximum width.

The pessary devices can have a minimum width from about 4 mm to about 28mm, about 5 mm to about 20 mm, about 8 mm to about 20 mm, from about 8mm to about 18 mm, or from about 8 mm to about 15 mm, such as, forexample, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, about 15 mm,about 15.5 mm, about 16 mm, about 16.5 mm, about 17 mm, about 17.5 mm,about 18 mm, about 18.5 mm, about 19 mm, about 19.5 mm, or about 20 mm,or any other suitable minimum width. The minimum width or diameter istypically measured at the narrowest portion of the pessary devicesubstantially perpendicular to the longitudinal axis.

The maximum width and the minimum width can be separated by any suitabledistance, such as, for example, by about 5 mm, about 10 mm, about 15 mm,about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about45 mm, about 50 mm, or any other suitable distance.

The pessary devices can have any suitable length, such as, for example,a length from about 35 mm to about 60 mm, about 40 mm to about 55 mm, orabout 40 mm to about 50 mm, such as, for example, a length about 35 mm,about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm,about 47 mm, about 48 mm, about 49 mm, or about 50 mm. The length istypically measured substantially parallel to the longitudinal axis ofthe pessary device.

Generally, the pessary device can have a weight of less than about 10grams, less than about 9 grams, less than about 8 grams, less than about7 grams, less than about 6 grams, less than about 5 grams, less thanabout 4 grams, less than about 3 grams, less than about 2 grams, orabout 1 gram, including for example, a weight of from about 1 gram toabout 7 grams, or from about 2 grams to about 6 grams, or from about 3grams to about 5 grams.

Pessary devices can be fabricated using any suitable materials andmethods. For example, pessaries can be formed from polymeric materials,such as, for example, polycarbonate, polyester, polyethylene,polyacrylamide, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, nylon, silicone, or mixtures or blends thereof, ormetallic materials. In certain embodiments, the pessary devices are notformed from absorbent material such as, for example, fibrous material orabsorbent foam.

Pessary devices can be formed in any suitable manner, such as, forexample, using injection molding or other suitable methods of formingthe pessary device.

The pessary device can be covered by an overwrap. The overwrap can benon-absorbent or absorbent and can include any suitable material, suchas, for example, a fibrous nonwoven material comprising natural,synthetic, or a blend of natural and synthetic fibers. Suitablesynthetic fibers can include, e.g., fibers such as polyester,polyolefin, nylon, polypropylene, polyethylene, polyacrylic, celluloseacetate, polyhydroxyalkanoates, aliphatic ester polycondensates,bicomponent fibers and/or mixtures thereof. Natural fibers can include,e.g., rayon and those commonly known to be non-synthetic and of naturalorigin such as cotton. The fibers can have any suitable cross-sectionalshape, such as, e.g., round, tri-lobal, multi-lobal, delta, hollow,ribbon-shaped, and/or any other suitable shape, or mixtures thereof.Fibers with any suitable width can be used, such as, e.g., from about0.5 to about 50 microns, such as, e.g., from about 1 to about 30microns, such as, e.g., from about 10 to about 25 microns. Fiber widthcan be determined using any suitable means; however, for non-roundfibers, width can typically be determined by reference to the width of afiber with the same cross-sectional area as the non-round fiber.

The overwrap can be made by any number of suitable techniques and canhave any suitable basis weight. Suitable techniques include, forexample, carding, meltblowing, spunbonding, spunlacing, air laying, andthe like. For example, the overwrap can be formed using bonding methods,such as, e.g., thermal, ultrasonic, resin, through-air bonding,hydroentangling, and/or needling. The basis weight of the overwrap canbe any suitable weight, such as, e.g., from about 10 to about 60 gramsper square meter (gsm), such as, e.g., from about 15 to about 30 gsm. Inaddition, the overwrap can be hydrophilic or hydrophobic.

The overwrap can be joined to the pessary device by any variety ofmeans. The overwrap can be joined to itself or to the pessary device.For example, one portion of overwrap can be joined to an opposed portionof the overwrap or to the pessary device using any suitable adhesive orheat pressure bonding means. Such adhesive can extend continuously alongthe length of attachment or it can be applied in a non-continuousfashion at discrete intervals. Heat bonding includes thermally bonding,fusion bonding, or any other suitable means for joining such materials.

The pessary device can include a withdrawal member that can comprise anysuitable material, including for example, cotton, cellulose, rayon,polyolefins such as, for example, polyethylene or polypropylene, nylon,silk, polytetrafluoroethylene, wax, or any other suitable materials.

The withdrawal member can be formed by any suitable formation method andin any suitable configuration, such as, e.g., one or more cords,strings, finger covers, ribbons, an extension of a material of thedevice, or combinations thereof.

The pessary device can be inserted using an applicator that can includean insertion member and a plunger. The insertion member can have aninsertion end and a withdrawal end opposite the insertion end. Theinsertion member also can include a barrel region adapted to contain thepessary device, and a grip region that can, in certain embodiments, bean indentation region provided opposite the insertion end, such as,e.g., proximal to the withdrawal end.

The insertion member and/or plunger can be constructed from any suitablematerial. Suitable materials include, for example, paper, paperboard,cardboard, cellulose, such as, e.g., molded cellulose, or anycombinations thereof, polyethylene, polypropylene, polybutylene,polystyrene, polyvinylchloride, polyacrylate, polymethacrylate,polyacrylonitrile, polyacrylamide, polyamide, nylon, polyimide,polyester, polycarbonate, polylactic acid, poly hydroxyalkanoate,ethylene vinyl acetate, polyurethane, silicone, derivatives thereof,copolymers thereof, mixtures thereof, or any suitable smooth plasticmaterial. Examples of suitable materials are disclosed in, e.g., U.S.Pat. Nos. 5,346,468 and 5,558,631. Additives can be included in thematerial to alter or enhance certain material properties. Suitableadditives include, for example, mold release agents, slip agents,surface energy modifiers, pearlescent agents, and/or any other suitableadditives. The insertion member also or alternatively can be coated witha substance to give it a high slip characteristic, such as, e.g., withwax, polyethylene, a combination of wax and polyethylene, cellophane,clay, mica, and other lubricants that can facilitate comfortableinsertion. Alternatively, or in addition, the insertion member caninclude a textured surface. Texture can be provided in any suitablemanner, such as, e.g., by designing texture into or adding texture tothe insertion member.

The insertion member can include a grip region, such as, for example, anindentation region. The grip region can have a plurality ofthree-dimensional surface elements, such as, e.g., projections, rings,ridges, ribs, embossments, depressions, grooves, and/or other grippingstructures. The three-dimensional surface elements can be provided inany suitable manner, such as, e.g., by the addition of material, and/orby impressing, such as, e.g., by embossing, or compressing the surfaces.For example, the indentation region can include one or more flattenedsides and/or one or more spaces for a decorative marking or a character,such as, e.g., an embossed and/or printed marking or character. Inaddition, or alternatively, the surfaces of the indentation region caninclude a material that can provide a frictional resistance for theuser's fingers during the insertion of the applicator into the body.Suitable materials that can provide friction include, for example,abrasive materials, high wet coefficient of friction materials, pressuresensitive adhesives, or any combinations thereof.

The pessary device can be used daily. For example, in certainembodiments, a user can insert the pessary device, wear the pessarydevice for a suitable wear time, such as, for example, up to 4 hours, upto 5 hours, up to 6 hours, up to 7 hours, up to 8 hours, up to 9 hours,up to 10 hours, up to 11 hours, or up to 12 hours, or more, remove thepessary device, dispose of the pessary device, and insert a new pessarydevice.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

All documents cited in the Detailed Description of the Invention are, inrelevant part, incorporated herein by reference; the citation of anydocument is not to be construed as an admission that it is prior artwith respect to the present invention. To the extent that any meaning ordefinition of a term in this document conflicts with any meaning ordefinition of the same term in a document incorporated by reference, themeaning or definition assigned to that term in this document shallgovern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. A non-expandable pessary device, the pessary device having a top, a base, a sidewall that extends between the top and the base, a length measured from the top to the base, a longitudinal axis, a maximum diameter, and a minimum diameter that is less than the maximum diameter, the sidewall, top and base forming an enclosed outer periphery defining a total area of the device, the pessary device having radial symmetry about the longitudinal axis and comprising a pressure region adapted to extend between an anterior vaginal wall and a posterior vaginal wall of a user to provide pressure on the user's urethra through the anterior vaginal wall, the pressure region comprising the maximum diameter, the pessary device further comprising a flexile region comprising the minimum diameter, wherein the flexile region is more flexible than the pressure region, wherein the maximum diameter is less than 25 mm and the maximum length is less than 60 mm.
 2. The pessary device of claim 1, wherein the base includes the pressure region.
 3. The pessary device of claim 1, wherein the top includes the pressure region.
 4. The pessary device of claim 1, wherein the pressure region is convex.
 5. The pessary device of claim 1, wherein the pessary device is in the shape of an hourglass, a waisted cylinder, a figure-8, a peanut, or a vase.
 6. The pessary device of claim 1, wherein the pessary device is a unitary construction.
 7. The pessary device of claim 1, wherein the flexile region is concave.
 8. A non-expandable pessary device, the pessary device having a top, a base, a sidewall that extends between the top and the base, a length measured from the top to the base, a longitudinal axis, a maximum diameter, a second diameter, and a minimum diameter that is less than the maximum diameter and the second diameter, the sidewall, top and base forming an enclosed outer periphery defining a total area of the device, the pessary device having radial symmetry about the longitudinal axis and comprising a first pressure region adapted to extend between an anterior vaginal wall and a posterior vaginal wall of a user to provide pressure on the user's urethra through the anterior vaginal wall, the first pressure region comprising the maximum diameter, wherein the maximum diameter is less than 25 mm and the length is less than 60 mm, the pessary device comprising a second pressure region comprising the second diameter, the second pressure region being provided apart from the first pressure region, the pessary device further comprising a flexile region comprising the minimum diameter, the flexile region being disposed between the first pressure region and the second pressure region.
 9. The pessary device of claim 8, wherein the first pressure region is convex.
 10. The pessary device of claim 8, wherein the pessary device is in the shape of an hourglass, a waisted cylinder, a figure-8, a peanut, or a vase.
 11. The pessary device of claim 8, wherein the pessary device is a unitary construction. 